The Trouble With Testing Part 1 — “No Responsibility at All”

“The White House is now home to an inattentive, conspiracy-minded president. We should not underestimate what that could mean.” — The Atlantic in a special report on U.S. pandemic preparedness during the July/August 2018 issue

“Anybody that wants a test can get a test. That’s what the bottom line is… and the tests are all perfect, like the letter was perfect. The transcription was perfect, right?” — Donald Trump on March 6 as U.S. was suffering a major shortage of COVID-19 test kits. 

“I take no responsibility at all.” — Donald Trump when asked if he felt any responsibility for the persistent lags in U.S. testing capability on March 13. 

“President Trump continues to falsely state that everyone who needs a COVID-19 test can get one.” — In an NPR interview conducted on April 2. 

“Two and a half months after the first reported coronavirus case in the US, America still doesn’t have the capacity that it needs to track all cases…” — Vox.

*****

The need for testing during a virus epidemic is directly related to the number of infected persons. If the outbreak is small, the need for testing is also proportionately smaller. And if the outbreak is large, then the need for testing is subsequently much larger.

Ironically, the more testing happens early on, the more cases are identified early on, the more contacts are traced and isolated early on, the more the virus is ultimately contained and the lower the follow-on need for tests. The inverse is also true. The less testing, identifying, and containing of pandemic illness early on, the more tests will later be needed.

A failure to test, trace and isolate in the U.S. early on resulted in a massive COVID-19 outbreak necessitating nationwide mitigation. 1 in 5 people tested in the U.S. are still showing up as positive as of April 20th — indicating that tests are generally still occurring only for high risk persons and not for the broader population. Image source: Our World in Data.

Because less testing, identification and containment means an illness like COVID-19 can expand undetected, exponentially, and with far less constraint. Each failure to respond to this nasty disease pushes us up the scale in the need for a still greater response in the form of testing, isolation, sanitation, and ultimately mitigation. And if leadership is incapable of providing that response in a continuous escalation, then we end up with an ever-expanding disaster. That’s what we face here in the U.S. Because here a national leadership under Trump that utterly lacks responsibility is showing its dramatic incapacity.

A Question of Responsibility

What is responsibility? At its root — response. In a disaster, swift, decisive, and effective response is what it takes to prevent an expanding and uncontainable cascade of harm, economic loss, and loss of life. Without leadership responsibility, a sense of duty to the persons under leadership’s charge and a willingness to answer to others, to positively absorb criticism, to act, to overcome barriers in order to make effective action possible, then crisis and disaster response itself will be set up to fail.

In the context of COVID-19, U.S. leadership failure by a corrupt and incompetent Trump Administration has weighed heavily in loss of life and well-being. Specifically, the Administration’s failure to take the responsibility necessary to provide the tests Americans need has been a critical aspect of this failure.

Test Development Timeline in a Global Context

Unlike South Korea which took swift action and outran global COVID-19 testing capability, the U.S. response under Trump in the form of deploying viable test kits, has lagged it.

On December 30 and 31 of 2019, China and WHO had identified pnemonia-like cases of a new illness. By January 10-12 of 2020, China released the new disease (later called SARS-CoV-2 for the virus or COVID-19 for the illness the virus causes) genome to the world. Within just a few days, German scientists, using SARS-CoV as a reference, had developed a test that could identify a unique portion of the SARS-CoV-2 virus’s DNA. On January 17, the World Health Organization (WHO) adopted the German-based test, published the guidelines for developing the test, and began working with private companies to rapidly produce those tests and distribute them. As other agencies developed new tests, WHO would also publicly provide the new formulas. For example, WHO published China’s test development formula one week later on January 24.

The importance of WHO action at this stage was threefold. First, it provided information on how to manufacture an effective test. In other words, any country could take the WHO-provided information and use it to mass produce its own tests. Like South Korea, they could then independently coordinate with medical industry to get the production chain rolling. Unlike South Korea, they no longer needed to independently develop one. A test formula was now publicly available. Second, the WHO began to manufacture test kits to send out to other nations who requested them. These manufactured kits provided physical samples of the published testing formula — making it easier for manufacturers in other countries to validate and reproduce. Third, WHO served as an agency that mass produced tests. This helped to provide tests to those who were unable to provide for themselves. By March 16, two months later, WHO alone had produced 1,500,000 tests and sent kits out to 120 countries.

The gene assay of SARS-CoV provided by Olfert Landt to the World Health Organization in January. This assay would result in an easily producible test that many nations would use to contain their COVID-19 outbreak. Image source: WHO.

Independently, the German firm that provided the first test protocol adopted by WHO was also shipping out tests to other countries. In mid-January, New Zealand, who decided the WHO-published test formula was good enough and the need for more immediate access to tests was greater than the need to independently produce one at home, ordered the Germany-developed kits. The kits were subsequently shipped. And New Zealand was provided with tests ahead of the outbreak that later occurred. In other words — they were prepared. Australia and a number of other countries made the same decision — also ordering their test kits from overseas. Olfert Landt’s firm, the German Agency that developed the first COVID-19 test protocol adopted by WHO, alone was shipping out 1,500,000 tests per week by late February of 2020.

U.S. — All Testing Eggs Slow-Walked into one Trump-Shrunken Basket

In the U.S., the Centers for Disease Control, a crucial public health protection organ, had long suffered budget cuts and diminishment under Trump. As noted before, each of Trump’s budgets had requested reduced funding for CDC and his attacks on the Affordable Care Act also degraded U.S. disease fighting capability. His removal of Obama’s Pandemic Task Force had cut off a federal limb that could have helped stop the virus in its tracks overseas, but if it did get out could have also coordinated infectious disease response at home and abroad, cut red tape, and sped the availability of materials such as test kits for the U.S. public.

Perhaps as equally pivotal, though, was Trump’s choice of director — Robert Redfield — to head CDC. Redfield, unlike many of Trump’s appointees, was certainly a professional with many years of experience in his field. One who spent 30 years researching HIV and for 20 years served in the U.S. Army Medical Corps. Redfield was, arguably though, far from a great choice to head the agency responsible for fighting disease in the U.S. He was embroiled in a controversy over an HIV vaccination trial in the 1990s in which he was accused of manipulating data. Redfield has also been criticized for allowing his strong religious beliefs to interfere with his medical views. Peter Lurie from the Center for Science in the Public Interest, a consumer advocacy group expressed this concern about Redfield’s appointment: “What one would get in Robert Redfield is a sloppy scientist with a long history of scientific misconduct and an extreme religious agenda.”

In choosing the controversial Redfield, Trump also passed over Anne Schuchat — a career public servant whose experience dealing with Anthrax in the U.S., Ebola in West Africa, and SARS in China made her an ideal choice for CDC head. In other words, an infectious disease expert with exactly the kind of experience to handle an illness like COVID-19. That’s what the people of the United States didn’t get from Trump. What we got was something that we’ve come to expect from a corrupt and incompetent Administration — at best a political appointee with professional credentials but also possessed of a questionable and often partisan-charged past, at worst the same but with no professional standing whatsoever.

As it happened, on the same day that WHO had published Olfert Landt’s test kit formula on its website, January 17, a sapped CDC in the U.S. announced that it had developed its own preliminary test for COVID-19. They’d decided to work on their own test. This decision was guided in part by regulation — and much of it for good reason. We didn’t want to open the door to fraudulent tests. But it was also a decision that occurred in the context of a global health emergency. And leadership from the top could have worked to ensure the protective needs of regulation were adhered to while still providing back-up options if the CDC-sponsored test kit development occurred too slowly or didn’t produce a usable test soon enough.

In other words, they could have cut red tape to enable medical industry in the U.S. to produce coordinate tests. Like South Korea, they could have called together industry heads and provided organization and guidance. Something a dedicated pandemic response team, had it been in place, could have helped to accomplish. Something a CDC head with novel pandemic chops like Anne Schuchat would have recognized the need for. CDC could have worked to validate those tests in conjunction with its own test. It could have used one of a number of WHO-validated formulas for these coordinate tests. It could have set up teams to work to validate multiple sets of tests to determine which ones were effective. It could have worked to set up contingency surge production if more tests were needed (as happened in South Korea and elsewhere).

The bio of Anne Schuchat — the kind of infectious disease expert that the U.S. is capable of fielding to head an effective pandemic response. The kind of expert the Trump Administration has repeatedly passed over in favor of less effective leaders. Image source: CDC.

Such a layered strategy did not develop at CDC under Redfield as head. At first, and for many weeks after, the decision by leadership was to support one testing regime and then to in a laissez faire way, ignore the fact that other agencies such as FDA ended up using existing regulation to defend it and to (unintentionally) stymie the independent development of effective tests in the U.S. In other words, through lack of response adequate to the threat of COVID-19, Trump’s CDC head put all their testing eggs into one basket.

Making Our Own Unluck

It all could have still worked out. The U.S. could have been lucky. The CDC test could have worked effectively. It could have arrived in time to help stop the virus. It could have arrived in enough numbers to meet the testing need. It could have been targeted to the regions that needed it most. Trump’s Redfield CDC hadn’t increased their likelihood of that success, though. They had greatly increased the opportunity for failure. And given that self-infliction of a worsened set of odds, things did not go well.

Development of the CDC test notably lagged behind the rest of the world. By January 21, the U.S. saw its first confirmed case of COVID-19. It was of a man who’d flown back from Wuhan, China and entered the U.S. on January 15. But it took another week — until January 28th for the CDC to provide its own test kit formula to WHO — 11 days later than Germany, four days later than China, and weeks after South Korea had developed an effective test protocol. Fully two weeks after the virus had arrived on U.S. shores.

It wasn’t until February 5 — fully 19 days after CDC’s first test protocol was announced — that a CDC under Trump had shipped 200 test kits to more than 100 public health labs across the U.S. These tests were enough to test 60,000 – 80,000 people if the kits proved effective. By the same time, WHO had shipped 250,000 tests that had already been validated. Globally, on February 5, confirmed cases had risen to above 28,000. In the U.S., 12 cases had been confirmed with cases springing up Washington State, Illinois, Wisconsin, California, Massachusetts, and Arizona. Given what we know about COVID-19, actual numbers were probably already much greater than these early confirmations indicated.

The virus had arrived on U.S. shores and CDC had scrambled to send out these test kits. But the test deployment would ultimately prove to be seriously problematic. The trouble with these U.S. tests ended up being four-fold. First, that they had not yet (by February 5) been validated and many would later prove useless. Second, there weren’t enough to meet demand. Third, many came too late. And fourth, test kit distribution was not targeted or weighted to the regions of highest need. Why the U.S. CDC response was so much slower and so poorly coordinated compared to those of other nations has not fully been explained. Nor has it been fully explained why many of the tests that CDC ultimately provided would fail. But this failure was arguably a major reason why COVID-19 would break out to such a great extent in the U.S. Why the U.S. would experience the worst first wave outbreak of this novel deadly illness. Because what ultimately happened was a serious failure to contain the illness once it reached our shores. To perform that detection, contacts tracing and isolation that was proving so useful in places like South Korea.

So by early February, CDC had shipped out about 200 test kits to public health labs across the country. Each kit contained enough material to test between 300 to 400 patients. But because kits were evenly distributed, places with much higher populations, places like public health labs in New York City which would later experience a devastating outbreak, only received enough testing material to test between 300-400 patients at that time. That’s 300-400 tests for a public health lab serving a city of 8.4 million souls.

According to a report from Kaiser:

The kits were distributed roughly equally to locales in all 50 states. That decision presaged weeks of chaos, in which the availability of COVID-19 tests seemed oddly out of sync with where testing was needed.

Another problem was that the test kits that were shipped out often proved faulty — lacking critical components that hobbled kits ability to produce results. So from February 5 to mid February — for about ten days or so — public health labs across the country were put in the position where they needed to validate CDC test kits. And, in most cases, the validation of a useful kit did not occur. By mid-February only about six public health labs had access to reliable tests. But the Trump-appointed CDC director Robert Redfield was at the time entrenched, defending those tests. He insisted that CDC had developed a “very accurate test.”

Global distribution of COVID-19 cases on February 20, 2020. Image source: World Health Organization.

At this point the official number of cases stood at 15. But we know that those numbers were growing unchecked. Mainly because the CDC test kits would prove inadequate. On February 24th, U.S. confirmed cases had jumped to 53 and health experts were saying that community spread was happening in the U.S. On the same day, The Association of Public Health Laboratories sent a plea letter to the FDA asking if states could develop their own testing protocols independent of the CDC. In a few days, FDA reversed its previous position of defending CDC tests as a national standard and allowed states to begin producing their own tests. By February 29, after 43 days, the CDC tests had only been used 472 times. An astonishingly small number compared to the 60,000 to 80,000 that the original test kits should have represented. The U.S. confirmed case total stood at 68. But hundreds more people had already been infected by the illness in the U.S. We just didn’t have much of a way to know who or where because the CDC-backed testing regime ended up being so abysmal.

March Explosion

In the race between testing to track the illness and COVID-19’s in-built imperative to grow beyond our control in the U.S., the virus was winning. It had gotten a big head start of about a month and a half.

By early March, as the number of tests in the U.S. was finally starting to expand, in large part due to rapid production of tests within states and independent of the Trump-hobbled CDC, U.S. confirmed case totals were rapidly shooting upwards. On March 7, confirmed U.S. cases had hit 435. Redfield on the same day noted about the CDC tests: “We found that, in some of the states, it didn’t work. We figured out why. I don’t consider that a fault. I consider that doing quality control. I consider that success.”

By the end of March the U.S. COVID-19 case total would be the largest in the world. This would necessitate a nationwide lockdown as containment failed risking hundreds of thousands of deaths. Image source: Worldometers.

In one more week, confirmed cases would multiply nearly sevenfold — hitting 2,770 by March 14. Tests were finally starting to work and be produced in larger numbers. But for the U.S., a new worrying statistic was starting to become evident — the number of positive cases per test was notably high. In total about 1 out of every 4-5 people receiving a test were testing positive. This was due to the fact that the primary location for U.S. testing was hospitals and emergency rooms. The U.S. did not have widespread dedicated test facilities like South Korea. So most people who got a test were already very ill. All of this was an indication that the U.S. barely understood even the tip of the COVID-19 iceberg that the country was slamming up against.

By March 21, the number of COVID-19 cases had again exploded — hitting 24,345 or nearly ten times their number from the prior week. States such as Washington, New York, and California were testing thousands of people per day now. And a disturbing understanding of the U.S. disease curve was starting to emerge. A model produced by the Imperial College in London projected that as many as 2.2 million people in the U.S. could die if the U.S. did not move strongly to mitigate the spread of the virus.

Moving To Mitigation as Virus Outruns Containment in a Big Way

Unlike testing, contacts tracing, and isolation, mitigation involves serious constraints on activity within the impacted regions. In effect it would mean lockdowns or stay at home orders for much of the nation. A kind of freeze placed on society and economies in order to reduce mass loss of life. We say reduce, because the mass casualty event for the U.S. had already gotten well out of the bag. Tens of thousands would already lose their lives as a result. The question now was between tens of thousands and hundreds of thousands or millions along with a smashed U.S. hospital system.

By March 31, U.S. cases had again exploded to nearly 190,000. Even more tragically, already more than 4,000 souls had been lost due to the virus. A Trump Administration that had promised to provide 27 million tests by that time had only seen the U.S. testing 1 million. And a good portion of these tests were provided not by the CDC or the federal government under Trump, they were provided by states who were forced to scramble to fill the yawning vacuum of a failed federal testing, contacts tracing and isolation response.

Most U.S. states now have more than 1,000 COVID-19 cases. Many now have more than 10,000 cases. The U.S. total will likely near 1 million by the end of April. This massive outbreak has forced large scale mitigation in which most states remain under stay at home orders. Image source: CDC.

Now states would have to step in again. This time to provide the mitigation necessary to prevent about 2.2 million deaths across the U.S., California’s Gavin Newsom issued a stay at home order on March 19, New York’s Governor, Andrew Cuomo, made a similar order just a day later on March 20th, Washington State’s order came on March 25th, Maryland’s own stay at home order began on March 30th. By the end of March, fully 42 states had issued a stay at home policy. A policy that would remain in place for many weeks to come. Containment had failed in a dramatic way. Testing still lagged well behind the need. People who wanted tests still couldn’t get them. And as U.S. COVID-19 case numbers climbed toward 1 million in April, testing would continue to lag the need for it in most places.

The result was a full-on move to mitigate COVID-19’s spread. But the failure to provide enough tests would still haunt the U.S. And a new issue with testing would emerge as debates on how to restart a hobbled U.S. economy in the presence of a widespread and terrible virus that had wafted its way into all corners of our nation would again emerge. Sadly, this debate would continue to include a tone of irrational defiance to advice provided by experts and to the larger threat posed by a deadly and as yet incurable illness from the Trump Administration and its political supporters.

(UPDATED)

Up next: It’s Everywhere Now — COVID-19 A Global Viral Wildfire

 

 

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7 Comments

  1. wharf rat

     /  April 21, 2020

    “New York’s Governor, Andrew Cuomo, issued a stay at home order on March 20th, Washington State issued a similar order on March 25th, Maryland’s own stay at home order began on March 30th.”

    The entire state of California started staying home on the 17th. The Bay Area started on the 13th. Here’s an article on how it began.

    Meet the doctor who ordered the Bay Area’s coronavirus lockdown, the first in the U.S.

    Under intense pressure, Sara Cody’s cohorts made the move ‘none of us really believed we would do’

    She is the Bay Area’s Anthony Fauci, Santa Clara County’s most “essential” employee, the one who banished us from Sharks hockey games, canceled her own daughter’s high school prom — and eventually shut in 6 million Bay Area residents in six neighboring counties to slow the stampede of a deadly pandemic.

    You could be forgiven if you’d never heard of Sara Cody before Jan. 31 — what seems like a century ago, when Kobe Bryant’s death was still what shocked us. That’s the day Dr. Cody was already feeling late, sitting at her dining room table in Old Palo Alto, gulping down a cup of coffee when her cellphone rang. It was 6:49 a.m.

    “You’ve got your first positive,” the voice said.

    https://www.mercurynews.com/2020/03/29/she-shut-down-the-bay-area-to-slow-the-deadly-coronavirus-none-of-us-really-believed-we-would-do-it/

    Liked by 1 person

    Reply
  2. Donald Campbell

     /  April 21, 2020

    Brazil, having just experienced a summer of intense infections, seems to suggest the adaptability of the virus, according to a recent article in the Guardian (https://www.theguardian.com/world/2020/apr/17/lula-bolsonaro-brazil-to-slaughterhouse-covid-19-coronavirus). One may assume that this virus will be with us for many months, perhaps years, having no significant seasonality. Thus research in antibody development and a vaccine should have the highest of priorities. Governments should collaborate because their economies depend on it.

    Liked by 1 person

    Reply
    • From all I’ve seen, many experts are warning that this disease does not have a winter seasonality. Which makes sense. It emerged in bats in the tropics and subtropics.

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  3. wharf rat

     /  April 22, 2020

    As people stay home, Earth turns wilder and cleaner

    An unplanned grand experiment is changing Earth.

    As people across the globe stay home to stop the spread of the new coronavirus, the air has cleaned up, albeit temporarily. Smog stopped choking New Delhi, one of the most polluted cities in the world, and India’s getting views of sights not visible in decades. Nitrogen dioxide pollution in the northeastern United States is down 30%. Rome air pollution levels from mid-March to mid-April were down 49% from a year ago. Stars seems more visible at night.

    People are also noticing animals in places and at times they don’t usually. Coyotes have meandered along downtown Chicago’s Michigan Avenue and near San Francisco’s Golden Gate Bridge. A puma roamed the streets of Santiago, Chile. Goats took over a town in Wales. In India, already daring wildlife has become bolder with hungry monkeys entering homes and opening refrigerators to look for food.

    When people stay home, Earth becomes cleaner and wilder.

    https://lasvegassun.com/news/2020/apr/21/as-people-stay-home-earth-turns-wilder-and-cleaner/

    Liked by 1 person

    Reply
  4. wharf rat

     /  April 23, 2020

    Like

    Reply

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